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The Arthrex Fiberwire™ and FiberTape™ Families are intended for use in soft tissue approximation and or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft or autograft tissues are used for repair.

Arthrex, Inc. suture grafting kits contain Fiberwire™ and FiberTape™ sutures of varying lengths and needle types, as components. The sutures are made of long chain polyesters and braided with a variety of cleared fiber material and sterilized for surgical use. They are available in dyed and non-dyed varieties, with or without needles.

The provided text is a 510(k) summary for a medical device (Arthrex Suture Grafting Kit), indicating substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study that proves the device meets those criteria, nor does it provide details about any clinical performance studies.

Therefore, I cannot fulfill your request for the specific details you asked for. The document focuses on regulatory approval based on equivalence to existing, cleared devices, rather than on the results of a new performance study with acceptance criteria.

Here's why the information you requested is not present in the provided text:

• Acceptance Criteria and Reported Device Performance: This document states the device's "Intended Use" and "Description," and argues "Substantial Equivalence" to predicate devices. It does not define specific performance metrics or acceptance criteria, nor does it report performance against such criteria.
• Sample Size, Data Provenance, Expertise, Adjudication, MRMC Study, Standalone Study, Ground Truth: These are all elements typically found in detailed study reports. This 510(k) summary is a high-level regulatory document that does not include such granular study details.
• Training Set Sample Size and Ground Truth Establishment: Similar to the above, these are specific to the development and validation of an algorithm, which is not the focus of this document.

The core of this 510(k) summary is to demonstrate that the "Arthrex Suture Grafting Kit" has the "same basic features and intended uses" as previously cleared predicate devices, and that "minor differences... do not raise any questions concerning safety and effectiveness and have no apparent effect on the performance, function, or intended use of this device." This is a regulatory pathway that relies on similarity to already approved devices, rather than a new clinical trial proving performance against defined criteria.

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